Mirvaso Gains CHMP Support for Rosacea Erythema Treatment

Miriam E. Tucker

Disclosures

December 20, 2013

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended marketing of brimonidine tartrate 3 mg/g topical gel (Mirvaso, Galderma) for the symptomatic treatment of facial erythema of rosacea in adult patients.

"The CHMP, on the basis of quality, safety and efficacy data submitted, considers there to be a favourable benefit-to-risk balance for Mirvaso and therefore recommends the granting of the marketing authorization," the committee said in a statement.

Brimonidine tartrate, categorized under "other dermatologicals," is a relatively selective alpha-2 adrenergic agonist with vasoconstrictive and vasostabilizing activity that counteracts the vasodilatation associated with rosacea erythema.

In 2 identically designed randomized studies, brimonidine produced statistically superior and clinically meaningful improvements compared with vehicle gel (P < .001).

The most common local adverse events associated with topical use of brimonidine tartrate are erythema, pruritus, flushing, and skin burning sensation. A pharmacovigilance plan for the product will be implemented as part of the marketing authorization.

Detailed recommendations for brimonidine's use will be published in the European public assessment report and made available in all official European Union languages after the marketing authorization has been granted by the European Commission, which is expected within 67 days.

The US Food and Drug Administration approved brimonidine for the same indication in August 2013.

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